Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery

Cardiovascular Diseases Clinical Trial

Official title:

Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02224222
• Other study ID #: VSZÉK-FRAILTY
• Status: Active, not recruiting
• Start date: July 2014
• Est. completion date: July 2020

Study information

• Verified date: April 2019
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to assess the impact of frailty as a multidimensional risk factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining patient frailty a multimodal questionnaire has been developed including measurement of psychological, socioeconomical, neurological and behavioral aspects. This study also features an investigation of the possible relationship between sudden regional weather changes, individual meteorological susceptibility of the patients and the outcomes of adult cardiac and vascular surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients, 18 years or older, admitted to the hospital for elective cardiac or vascular surgery.

Exclusion Criteria:

• Not willing to participate.

• Pregnant women.

• During active psychiatric hospital care.

• Patients with defined legal incapability or limited capability.

• Congenital or acquired speech impediment and locomotion disability of any kind.

• Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).

• Patients admitted solely for elective surgery of the varices of the lower extremities.

• Patients with a transplanted heart.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Frailty
• Heart; Dysfunction Postoperative, Cardiac Surgery
• Infarction
• Intellectual Frailty of Aging
• Myocardial Infarction
• Vascular Diseases

Locations

Country	Name	City	State
Hungary	Semmelweis University, Heart and Vascular Center	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital and intensive care unit stay.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	The composite of in-hospital death from any cause.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	Evidence of clinically definite postoperative acute kidney injury and the need for dialysis.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	Evidence of clinically definite postoperative low cardiac output syndrome.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	Evidence of clinically definite postoperative cardiac arrythmias.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	Evidence of clinically definite postoperative SIRS.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	Evidence of clinically definite postoperative acute lung injury and the need for mechanical ventilation.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	Evidence of clinically definite postoperative peripheral vascular insufficiency.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	The need for reoperation due to bleeding.		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.